Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors

Study Purpose

This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	15 Years - 39 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Age 15-39 years.

- With primary brain tumor with cranial radiotherapy.

- 6 months to 4 years post cranial radiotherapy.

- Functional Assessment of Cancer Therapy (FACT)-Cognitive Function score < 60 based on self-report (used among AYAs with non-neural cancer) - Able to provide informed consent/assent.

- Able to walk and receive clearance from a provider to participate based on the Physical Activity Readiness Questionnaire.

- Currently engaging in < 150 minutes of physical activity per week.

- Willing to use smartphone-based applications (app)
Exclusion Criteria:
- Secondary malignancies, germline genetic syndrome, or recurrent disease requiring re-irradiation of the brain.

- Moderate to severe traumatic brain injury with brain damage beyond that expected from brain tumor and treatment.

- Developmental disorders (e.g., autism) or major psychotic illness (e.g., schizophrenia, depression) to avoid confounding impact related to these disorders

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06799481
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Emory University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jinbing Bai, PhD, RN
Principal Investigator Affiliation	Emory University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm

Additional Details

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of conducting a two-site pilot randomized controlled trial (RCT) to test the RISE in AYA brain tumor survivors.

II. Examine the impact of RISE on CRCI (primary) and physical activity (secondary).

EXPLORATORY OBJECTIVE:

I. Explore the impact of RISE on the gut microbiome diversity and composition.

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (RISE INTERVENTION): Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12. ARM II (ATTENTION CONTROL): Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12. After completion of study intervention, patients are followed up at week 18.

Arms & Interventions

Arms

Experimental: Arm I (RISE)

Patients receive access to Physitrack and participate in personalized, progressive aerobic training over 30-40 minutes 3-5 days a week and strength training exercises 2 days a week for 12 weeks. Patients also receive active lifestyle behavior coaching over 10 minutes on 2 days a week for weeks 1-4 and then once weekly for weeks 5-12.

Active Comparator: Arm II (attention control)

Patients receive calls from the trainer once weekly for 12 weeks. Patients also wear a Fitbit for 7 days at baseline to week 12.

Interventions

Other: - Aerobic Exercise

Participate in personalized, progressive aerobic training

Behavioral: - Behavioral Intervention

Receive active lifestyle behavior coaching

Procedure: - Follow-Up

Receive calls from the trainer

Other: - Internet-Based Intervention

Receive access to Physitrack

Other: - Medical Device Usage and Evaluation

Wear a Fitbit monitor

Other: - Questionnaire Administration

Ancillary studies

Other: - Resistance Training

Participating in strength training exercises

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emory University Hospital, Atlanta, Georgia

Status

Recruiting

Address

Emory University Hospital

Atlanta, Georgia, 30322

Site Contact

Emily Bush, BS

[email protected]

404-727-2466

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